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Zorifertinib

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Zorifertinib

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Zorifertinib
Generic Name (API): Zorifertinib
Dosage Form & Strength: 50 mg, 100 mg
Route: Oral
Drug Class: EGFR tyrosine kinase inhibitor (blood-brain barrier penetrant)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Zorifertinib Used For?

Zorifertinib is a targeted tablet for EGFR-mutated lung cancer that has already spread to the brain. It was developed by Alpha Biopharma (Jiangsu) in China, where it is sold as 泽瑞尼® (Zorifer®), and it was built from the start to reach the brain and spinal fluid, which many older lung cancer tablets struggle to do.

China's National Medical Products Administration (NMPA) approved it in November 2024 as a first-line treatment for adults with:

  • Locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • With an EGFR exon 19 deletion or exon 21 L858R mutation, confirmed by a validated test
  • That has spread to the central nervous system (CNS), such as brain metastases

It is a prescription cancer medicine and should only be used under a medical oncologist experienced in lung cancer.

How It Works

In these cancers, a faulty EGFR protein keeps telling tumour cells to grow. Zorifertinib blocks that signal. What sets it apart is its design: the brain has pumps that push most medicines back out, and zorifertinib was made so those pumps do not remove it. According to the Chinese label, its level in the spinal fluid is roughly the same as the free level in the blood, so it can act on tumours inside the brain as well as in the chest.

What the Trial Showed

The approval rests on the phase 3 EVEREST trial, published in Med (Zhou Q et al., 2025). It enrolled 439 people with newly diagnosed EGFR-mutated lung cancer and untreated brain metastases, who took either zorifertinib or a comparison medicine from an older generation of EGFR tablets.

  • Median time before the cancer grew anywhere in the body was 9.6 months, against 6.9 months (a 28% lower risk of progression)
  • Median time before the brain tumours grew was 15.2 months, against 8.3 months, as assessed by independent reviewers
  • 68.6% of patients responded to treatment, compared with 58.4%
  • Survival data were not yet mature when the results were published

Recommended Dosage

According to the Chinese prescribing information:

  • 200 mg twice a day by mouth, about 12 hours apart, at the same times every day
  • It can be taken on an empty stomach or after a normal or medium-fat meal (there is no data after a high-fat meal)
  • A missed dose can be taken if fewer than 4 hours have passed; otherwise skip it. If you vomit after a dose, do not take another one
  • Treatment continues until the disease progresses or side effects become too hard to manage
  • If side effects need it, the doctor can lower the dose step by step to 150 mg, 100 mg or 50 mg twice a day

The tablets come in 50 mg and 100 mg strengths, so the usual 200 mg dose is two 100 mg tablets. Your oncologist sets the exact plan.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Skin and diarrhoea: these are the side effects most people notice. In EVEREST, 92.7% of patients had a rash or acne-like skin reaction (severe in 30.5%) and 64.5% had diarrhoea (severe in 13.2%). Gentle skin care, sun protection and early anti-diarrhoea treatment help a lot, and the dose can be paused or reduced.

  • Liver tests: raised liver enzymes were very common (AST 72.3%, ALT 68.2%), mostly mild. Liver tests are checked regularly, and treatment is paused or reduced if the levels climb too high.
  • Heart rhythm (QTc): QTc prolongation was seen in 14.1% (severe in 4.1%). An ECG and blood salts such as potassium and magnesium are checked before and during treatment. Low potassium was reported in 29.1%.
  • Mouth, nails and appetite: mouth sores (39.5%), nail-fold infection (30.0%) and loss of appetite (41.8%) were also frequent.
  • Lung inflammation (ILD): no confirmed cases were seen among 250 patients on the 200 mg dose, but it is a known risk with this type of medicine. Report new or worsening cough, breathlessness or fever at once. If ILD is confirmed, the medicine is stopped for good.
  • Other medicines: strong CYP3A4 inducers or inhibitors can change the level of this medicine in the blood and should be avoided. Give your doctor a full list, including herbal products.
  • Pregnancy: it can harm an unborn baby and must not be used in pregnancy. Both men and women should use effective contraception during treatment and for 3 months after the last dose, and breastfeeding should stop during treatment and for at least 3 months afterwards.

Overall: in the trial, 50.9% of patients needed a pause in treatment and 50.0% had the dose lowered because of side effects, while 7.3% stopped permanently. Safety in children under 18 has not been established.

How to Access Zorifertinib in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Zorifertinib to India?

The tablets can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified medical oncologist
  • Diagnostic reports, including the biopsy report, the EGFR mutation test (exon 19 deletion or L858R) and brain MRI or CT showing the metastases
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Zorifertinib available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. For other EGFR lung cancer situations, see our pages on Zegfrovy and Lazcluze.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. Each bottle holds 28 tablets, so at the usual dose of two 100 mg tablets twice a day, one bottle of 100 mg tablets lasts one week. We plan supply month by month so treatment is not interrupted. The label says to keep the bottle tightly closed and below 30°C, and the tablets travel in their sealed original bottles under temperature-controlled shipping. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or the treating hospital on a valid oncologist's prescription.

Delhi

Large cancer centres in Delhi treat lung cancer patients from across North India, and our New Delhi dispatch point means the tablets can reach them quickly.

Mumbai

Oncologists in Mumbai can request the medicine for a named patient once the EGFR report and brain scans are shared.

Bangalore

Patients in Bangalore can have monthly supplies delivered to their home or to the hospital pharmacy.

Chennai

A major referral hub for lung cancer in South India, where many patients are already treated for brain metastases.

Hyderabad

We plan each month's bottles ahead so there is no gap between supplies.

Kolkata

Patients in Kolkata and the eastern states can use the same documented import route, with updates at every stage.

Pune

The treating oncologist can send us the prescription and test reports to start the import.

Ahmedabad

Oncologists in Ahmedabad can coordinate access for patients whose cancer has spread to the brain.

Jaipur

Patients across Rajasthan can receive the tablets without travelling, as long as the import is in their name.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating hospital.

Lucknow

We coordinate delivery for patients treated at public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can have their supply delivered to Kochi and nearby cities.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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